FDA Device recall Z-0543-2016
Cardinal Health Tiny Toes
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Cardinal Health Tiny Toes by Philips Electronics North America, citing heel warmers may cause first and second degree burns.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0543-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-20 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Electronics North America |
| Distribution | MO |
Product
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Reason
Heel warmers may cause first and second degree burns.
Identifiers
| code_info | All product in distribution |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0543-2016%22
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